Skip to content

Lead, Sutureless Myocardial

by Daig Corp. 510(k)

Active United States

510(k) K782087

Overview

This device is a Permanent Pacemaker Electrode, designed for myocardial attachment without sutures. It is intended for implantation in the heart to facilitate electrical conduction, serving as a component in pacemaker systems for patients requiring cardiac rhythm management.

The Lead, Suturless Myocardial is supplied sterile and intended for single-use. It is classified as a Class III medical device under FDA regulations (870.3680) and has received FDA 510K clearance through a Traditional pathway. Implantation is performed in a sterile operating environment, typically within a cardiac catheterization lab or surgical suite, and requires adherence to standard aseptic techniques.

AI-generated from registry data, 18 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK782087 Date15 Jan 1979ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DTB
Device Class
Class III
Regulation
21 CFR Part 870.3680
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Other devices from Daig Corp.

See all devices from Daig Corp. →

Questions

  • What is the primary purpose of the Lead, Suturless Myocardial device in a pacemaker system?

    The Lead, Suturless Myocardial is designed specifically for myocardial attachment without sutures, enabling secure implantation in the heart. Its purpose is to facilitate electrical conduction as part of a pacemaker system, ensuring proper cardiac rhythm management for patients who require it. This eliminates the need for traditional suturing, simplifying the implantation process while maintaining functionality.

  • How is the Lead, Suturless Myocardial supplied, and what are its usage restrictions?

    The device is supplied sterile and is intended for single-use only, meaning it should not be reused after implantation. Since it is classified as a Class III medical device and requires implantation in a sterile environment (such as a cardiac catheterization lab or surgical suite), proper aseptic techniques must be followed during use to prevent infection or complications.

  • What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its use?

    The Lead, Suturless Myocardial received FDA 510K clearance through the Traditional pathway, meaning its safety and effectiveness were compared to a legally marketed predicate device. This clearance confirms that the device meets FDA standards for permanent pacemaker electrodes and is authorized for use in cardiac rhythm management as part of a pacemaker system, adhering to established guidelines for Class III devices.

  • Where and how should this device be stored before use, given its sterile and single-use nature?

    Since the Lead, Suturless Myocardial is sterile and intended for single-use, it should be stored in its original packaging in a clean, dry environment away from direct sunlight or extreme temperatures. The packaging must remain intact until immediate use to maintain sterility, and it should be handled using aseptic techniques to prevent contamination before implantation.